Table 1.
Baseline characteristics in patients ≥65 years.a
| Characteristic | Axi-Cel, N = 51 | SOC, N = 58 | Overall, N = 109 |
|---|---|---|---|
| Median age (range), years | 70 (65–80) | 69 (65–81) | 69 (65–81) |
| Male sex, n (%) | 28 (55) | 39 (67) | 67 (61) |
| Race or ethnic group, n (%)b | |||
| American Indian or Alaska Native | 0 | 1 (2) | 1 (1) |
| Asian | 2 (4) | 2 (3) | 4 (4) |
| White | 47 (92) | 54 (93) | 101 (93) |
| Other | 2 (4) | 1 (2) | 3 (3) |
| Hispanic or Latino ethnic group, n (%)b | |||
| Yes | 3 (6) | 4 (7) | 7 (6) |
| No | 47 (92) | 53 (91) | 100 (92) |
| Not reported | 1 (2) | 1 (2) | 2 (2) |
| ECOG performance status score of 1, n (%)c | 26 (51) | 22 (38) | 48 (44) |
| Disease stage, n (%) | |||
| I-II | 9 (18) | 14 (24) | 23 (21) |
| III-IV | 42 (82) | 44 (76) | 86 (79) |
| sAAIPI of 2–3, n (%)d,e | 27 (53) | 18 (31) | 45 (41) |
| Molecular subgroup according to central laboratory, n (%)f | |||
| Germinal center B-cell–like | 32 (63) | 34 (59) | 66 (61) |
| Activated B-cell–like | 3 (6) | 3 (5) | 6 (6) |
| Unclassified | 4 (8) | 3 (5) | 7 (6) |
| Not applicable | 7 (14) | 7 (12) | 14 (13) |
| Missing data | 5 (10) | 11 (19) | 16 (15) |
| Disease type according to central laboratory, n (%) | |||
| DLBCL not otherwise specified/without further classification possibleg | 33 (65) | 42 (72) | 75 (69) |
| HGBL, including rearrangement of MYC with BCL2 or BCL6 or both | 12 (24) | 7 (12) | 19 (17) |
| Not confirmed or missing data | 5 (10) | 7 (12) | 12 (11) |
| Other | 1 (2) | 2 (3) | 3 (3) |
| Disease type according to the investigator, n (%) | |||
| DLBCL not otherwise specified | 27 (53) | 40 (69) | 67 (61) |
| T-cell/histiocyte-rich LBCL | 0 | 1 (2) | 1 (1) |
| Large cell transformation from follicular lymphomah | 7 (14) | 9 (16) | 16 (15) |
| HGBL with/without MYC and BCL2 and/or BCL6 rearrangement | 17 (33) | 8 (14) | 25 (23) |
| Prognostic marker according to central laboratory, n (%) | |||
| HGBL, double or triple hit | 12 (24) | 7 (12) | 19 (17) |
| Double-expressor lymphoma | 20 (39) | 23 (40) | 43 (39) |
| MYC rearrangement | 4 (8) | 2 (3) | 6 (6) |
| Not applicable | 15 (29) | 21 (36) | 36 (33) |
| Missing data | 0 | 5 (9) | 5 (5) |
| Response to 1L therapy, n (%)e | |||
| Primary refractory | 37 (73) | 39 (67) | 76 (70) |
| Relapse ≤12 months after initiation or completion of 1L therapy | 14 (27) | 19 (33) | 33 (30) |
| Bone marrow involvement, n (%)i | 1 (2) | 4 (7) | 5 (5) |
| Elevated LDH level, n (%)j | 31 (61) | 24 (41) | 55 (50) |
| Median tumor burden (range), mm2,k | 1826 (181–22538) | 1722 (252–16649) | 1775 (181–22538) |
Abbreviations: 1L, first-line; DLBCL, diffuse large B-cell lymphoma; ECOG, Eastern Cooperative Oncology Group; HGBL, high-grade B-cell lymphoma; LDH, lactate dehydrogenase; sAAIPI, second-line age-adjusted International Prognostic Index.
aPatients were randomly assigned to receive axi-cel or SOC. Percentages may not total 100 because of rounding.
bRace and ethnic group were determined by the investigator.
cEastern Cooperative Oncology Group (ECOG) performance status scores are assessed on a 5-point scale, with a score of 0 indicating no symptoms and higher scores indicating greater disability. A score of 1 indicates that the patient is ambulatory but restricted from strenuous activity. Only patients with an ECOG performance status score of 0–1 were included in the study.
dValues are the sAAIPI at randomization, which were like the sAAIPI according to the investigator as entered into the clinical database. The sAAIPI is used to assess prognostic risk based on various factors after adjustment for patient age and extranodal status at the time of diagnosis of refractory disease; risk categories are assessed as low (0 factors), intermediate (1 factor), or high (2 or 3 factors).
eAs reported by investigator at time of randomization via Interactive Voice/Web Response System.
fThe molecular subgroup as assessed by the investigator was as follows: germinal center B-cell–like in 28 patients (55%) in the axi-cel arm, 24 (41%) in the SOC arm, and 52 (48%) overall; non–germinal center B-cell–like in 15 (29%), 21 (36%), and 36 (33%), respectively. The molecular subgroup was not assessed in 8 patients (16%) in the axi-cel arm, 13 (22%) in the SOC arm, and 21 (19%) overall.
gThe definition of DLBCL according to the central laboratory included cases of incomplete evaluation that were due to inadequate sample amount or sample type, for which further classification of the subtype was not possible. DLBCL, not otherwise specified, according to the World Health Organization 2016 definition (16), is also included.
hTransformation was defined as the presence of large cells noted anywhere in the biopsy sample.
iThe data shown were as collected on the diagnosis history case-report form.
jAn elevated lactate dehydrogenase level was defined as a level that was above the upper limit of the normal range per local laboratory reference range.
kTumor burden was determined on the basis of the sum of product diameters of the target lesions, according to the Cheson criteria (54) and was assessed by the central laboratory.